Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

Last updated: January 3, 2024
Sponsor: Viome
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anxiety Disorders

Panic Disorders

Kleptomania

Treatment

VIOME Precision Nutrition Program

Control arm

Clinical Study ID

NCT06190184
V211.3.1
  • Ages > 25
  • All Genders

Study Summary

US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of two arms. This study is direct to participant and will not utilize clinical sites.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Resident of the United States
  • 50 years old and older OR BMI of 25 or greater
  • Able to speak and read English
  • No unexplained weight loss, fevers, anemia, or blood in stool
  • Willing and able to follow the trial instructions, as described in the recruitmentletter
  • Signed and dated informed consent prior to any trial-specific procedures.
  • PHQ9 score of 5-24 (inclusive)

Exclusion

Exclusion Criteria:

  • Unwilling to change their current diet
  • Prior use of Viome products or services
  • Antibiotic use in the previous 4 weeks
  • Pregnancy (current or planned in the next 4 months)
  • < 90 days postpartum
  • Breast feeding
  • Active infection
  • Unable or unwilling to use Viome's App on an iPhone or Android smartphone
  • Significant diet or lifestyle change in the previous 1 month
  • IBD diagnosis -Major psychiatric/DSM-4 disease diagnosis (e.g. Schizophrenia, Bipolardisorder, Post- traumatic Stress Disorder, Obsessive Compulsive disorder)
  • Use of investigational drugs, products or devices within 1 month prior to and 4 monthsafter the start of the trial
  • Cancer therapy within the previous 1 year
  • Major surgery in the last 6 months or planned in the next 4 months
  • Allergies to any supplement ingredients listed in the screening survey
  • Currently on a specific diet: FODMAP, KETO, PALEO
  • Answered yes to the question, "In the past few weeks, have you wished you were dead orhad thoughts about killing yourself?"
  • Gastrointestinal disease including:
  • GI surgery except:
  • Appendectomy and benign polypectomy
  • Esophagitis
  • Celiac disease
  • GI malignancy or obstruction
  • Peptic Ulcer Disease
  • Duodenal or gastric ulcer disease

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: VIOME Precision Nutrition Program
Phase:
Study Start date:
October 26, 2023
Estimated Completion Date:
December 31, 2024

Study Description

Participants who meet the eligibility criteria are randomized into any of the two arms including: the placebo arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo and Viome's Precision Nutrition Program include supplements and/or dietary recommendations towards improving the symptoms associated with metabolic wellness. The trial will last approximately 4 months for each participant.

Connect with a study center

  • Viome Life Sciences

    Bothell, Washington 98011
    United States

    Active - Recruiting

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